RESPIKAST 4 montelukast (as sodium) 4 mg chewable tablet blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
28-11-2017
Active ingredient:
montelukast sodium
Available from:
Torrent Australasia Pty Ltd
INN (International Name):
montelukast sodium
Authorization status:
Registered
Patient Information leaflet
RESPIKAST
MONTELUKAST_ (_AS SODIUM) CHEWABLE TABLETS 4 MG
MONTELUKAST_ (_AS SODIUM) CHEWABLE TABLETS 5 MG
MONTELUKAST _(_AS SODIUM) TABLETS 10 MG
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Respikast. It does
not contain all the
available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed the risks of you taking Respikast
against the benefits they
expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist. Keep this
leaflet with the medicine.
You may need to read it again.
WHAT RESPIKAST IS USED FOR
Respikast is used to prevent asthma symptoms, including those that
occur during the day and
at night-time. It also prevents the narrowing of airways triggered by
exercise. If you have
seasonal allergic rhinitis (hay fever), Respikast also treats your
allergic rhinitis symptoms. It
can be used in children 2 years of age and older, teenagers and
adults.
Respikast tablets are not used to treat an acute attack of asthma. If
an acute attack occurs,
follow your doctor's instructions for your reliever medicine, and keep
taking your Respikast
each night or as prescribed.
As a preventive medicine for asthma, Respikast can be used alone or in
combination with other
preventive medicines, such as inhaled corticosteroids. Your doctor may
reduce your dose of
inhaled corticosteroid while you are taking Respikast .
Asthma is a lung disease and has the following characteristics:
•
narrowed airways causing breathing to become difficult
•
inflamed airways, which means the lining of airways become swollen
•
sensitive airways that react to many things, such as cigarette smoke,
pollen, or cold air.
Symptoms of asthma include coughing, wheezing and chest tightness. Not
all people with
asthma wheeze. For some, coughing may be the only symptom of asthma.
Symptoms often
occur during the night or after exercise.
For further information a
Read the complete document
Summary of Product characteristics
Page 1 of 23
PRODUCT INFORMATION
RESPIKAST 4MG, 5MG AND 10MG
NAME OF MEDICINE
Montelukast sodium
DESCRIPTION
Montelukast sodium, the active ingredient in Respikast, is a selective
and orally active
leukotriene receptor antagonist that inhibits the cysteinylleukotriene
CysL
T1 receptor.
Montelukast
sodium
is
described
chemically
as
sodium
[1-[[[(1
_R_
)-1-[3-[(
_E_
)-2-(7-
chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(1-hydroxy-1-
methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate.
The
empirical
formula
is
C
35
H
35
ClNNaO
3
S, and
its
molecular
weight
is
608.18.
The
structural formula is:
CAS NUMBER: 151767-02-1
Montelukast sodium is a hygroscopic, optically active, white to
off-white, free-flowing
powder. Montelukast sodium is freely soluble in ethanol, methanol, and
water and practically
insoluble in acetonitrile. Montelukast is the optically active R
stereoisomer.
Each 10-mg tablet contains 10.4 mg montelukast sodium, which is
equivalent to 10.0 mg of
montelukast, the free acid. Each 5-mg chewable tablet contains 5.2 mg
montelukast sodium,
which is equivalent to 5.0 mg of montelukast, the free acid. Each 4-mg
chewable tablet
contains 4.16 mg montelukast sodium, which is equivalent to 4.0 mg of
montelukast, the free
acid.
Each 10-mg tablet contains the following inactive ingredients:
mannitol, microcrystalline
cellulose,
croscarmellose
sodium,
iron
oxide
red,
iron
oxide
yellow,
cherry
flavour,
aspartame and magnesium stearate. Each 4-mg and 5-mg chewable tablet
contains the
following
inactive
ingredients:
mannitol,
microcrystalline
cellulose,
iron
oxide
red,
croscarmellose sodium, cherry flavour, aspartame, and magnesium
stearate.
Page 2 of 23
PHARMACOLOGY
PHARMACODYNAMICS
The
cysteinyl
leukotrienes
(LTC
4
,
LTD
4
,
LTE
4
),
are
potent
inflammatory
eicosanoids
released from various cells including mast cells and eosinophils.
These important pro-
asthmatic mediators bind to cysteinyl leukotriene (CysLT) receptors.
The CysLT type-1
(CysLT1) receptor is found in the human airway (including airway
smooth mus
Read the complete document
